Kornimate/medical-research-clean huggingface dataset:
centrimag rvas u.s. post-approval study protocol

Conditions: Right Ventricular Failure

Summary: the study objective is to gather post-market clinical data on the use of the centrimag rvas when used for temporary mechanical circulatory support of the right ventricle in patients with acute right ventricular failure from any cause

objectives of this study are to evaluate: 1. duration of right ventricular support 2. incidence of adverse effects 3. evaluation of end-organ function 4. evaluation of hemodynamics 5. survival at 30 days post rvad removal the primary endpoints include: 1. in patients who recover and do not go on to transplantation or a long-term device: a. survival to 30 days post-support or to hospital discharge (whichever is longer) 2. in patients who do not recover and are bridged to transplant or a long-term system: 1. survival to induction of anesthesia for implantation of a long-term mechanical support device or heart transplant secondary endpoints include: 1. on pump hemodynamics 1. a clearly observable trend toward reduction of mean right atrial pressure / central venous pressure is demonstrated while the patient is on support compared to baseline. 2. a clearly observable trend toward an increase in mean arterial pressure is demonstrated while the patient is on support compared to baseline 3. a clearly observable trend toward an increase in mean cardiac index is demonstrated while the patient is on support compared to baseline 2. post pump hemodynamics (must meet at least two of the following criteria) 1. based on plotting of the data, success will be achieved if a clearly observable trend toward reduction of mean right atrial pressure/central venous pressure is demonstrated after device removal compared to baseline 2. based on plotting of the data, success will be achieved if a clearly observable trend toward increase in mean arterial pressure is demonstrated after device removal compared to baseline 3. based on plotting of the data, success will be achieved if a clearly observable trend toward increase in mean cardiac index is demonstrated after device removal compared to baseline 3. a clearly observable trend toward a reduction in creatinine and/or bun while on support and after device removal compared to baseline 4. a clearly observable trend toward a reduction in total bilirubin while on support and after device removal compared to baseline 5. an acceptable incidence of adverse effects observed patient population this study includes data from 25 consecutive patients with acute right ventricular failure from any cause requiring use of the centrimag rvas to sustain life.

Eligibility criteria:
inclusion criteria: * right ventricular failure from any cause exclusion criteria: * primary coagulopathy or platelet disorders * allergy or sensitivity to heparin and all alternative anticoagulants

Keywords: heart failure right ventricular failure levitronix thoratec corporation
this study aims to measure the effect of acute hospitalisation on the physical and cognitive functioning of older orthopaedic patients (aged 65 or above).

Conditions: Deconditioning; Orthopedic Fractures; Hospital Associated Deconditioning; Orthopaedic Injuries

Summary: this study aims to investigate the impact of hospitalisation on physical and cognitive performance in patients aged 65 and older admitted with an orthopaedic injury. this will be achieved by asking patients to participate in a series of physical and cognitive performance questionnaires and tests. these questionnaires and tests will be performed by the patients as close to their admission as possible and then again at day 7 of hospitalisation (or discharge if earlier) and at 4-6 weeks after discharge. however, if a patient's hospital stay lasts more than 30 days, they will be asked to take part in the interim data collection timepoint. to summarize, patients will be assessed at least 3 times, 4 if your hospital stay is longer than 30 days. the first and second assessments will be in the hospital, and the third will be 4-6 weeks after discharge at you home (or where is appropriate). additionally, patients will be asked to wear an activity watch between the first and second assessment. the study will also explore patients experiences of their hospital stay and opinions on deconditioning, including the views and opinions of hospital staff. this information will be gathered by having interviews with a sample of the patients who took part in the questionnaires and tests and by having interviews with hospital staff. the interview will be conducted by the main researcher, thomas cartledge, and will take place either over the phone, online or in-person, depending on your preference. the interviews will be audio and/or video recorded, however the recordings will be deleted immediately once transcription is completed. the duration of the interview will last approximately 30-60 mins.


Eligibility criteria:
patient criteria: inclusion: * older adults aged 65 years or older * able to provide written consent * admitted to southampton general hospital (sgh) for an acute orthopaedic condition * been admitted to sgh \<72 hours before recruitment exclusion: * older adults who are not able to safely complete the quantitative measurement tools, as advised by the patient's clinician * patients receiving end of life care * require a hoist to transfer from bed to chair prior to hospitalisation * been admitted to sgh \>72 hours before recruitment * unable to consent hospital staff criteria: inclusion: * work at sgh * work with older orthopaedic inpatients * be able to provide written consent

Keywords: hospital acquired deconditioning hospital associated deconditioning physical functioning cognitive functioning orthopaedic older patient older adults (65 years and older) muscle strength muscle mass
cognitive behavioural therapy for youths with depressive and anxiety symptoms in hong kong

Conditions: Depressive Symptoms; Anxiety Symptoms

Summary: the proposed study is a randomized controlled trial (rct) that aims to examine the effectiveness of cognitive behavioural therapy in reducing depressive and anxiety symptoms for youths in hong kong. it is to be carried out with 120 youths aged 12 - 24 recruited from a series of community-based levelmind@jc hubs, funded by the hong kong jockey club charities trust. it is designed to improve the youths' abilities/ skills in handling moods to have better emotional management. a written informed consent will be signed by participants. researchers will perform cognitive behavioural therapy on youths who agree to join the study.


Eligibility criteria:
inclusion criteria: * levelmind@jc users with mild to moderate distress level (n=120); * have sufficient proficiency in chinese to understand verbal instructions and give informed consent; exclusion criteria: * known diagnosis of intellectual disability * organic brain disorder * photosensitive epilepsy * significant visual, auditory or balance impairment * current or previous use of illicit drugs * known psychiatric diagnosis (stabilized diagnosis and treatment) * receiving any psychosocial treatment for social withdrawal such as cbt or; * current or active suicidal ideation or attempts.

Keywords: randomized controlled trial cognitive behavioural therapy youths depressive and anxiety symptoms
topical application of as101 for the treatment of psoriasis

Conditions: Mild to Moderate Psoriasis

Summary: this protocol relates to a phase ii randomized double blind, placebo controlled study of the as101 topical application for the treatment of mild to moderate psoriasis.


Eligibility criteria:
inclusion criteria: 1. patient have a diagnosed mild to moderate stable plaque type psoriasis (less than 10% of body skin surface). 2. patient must be 18-70 years of age. 3. general health must be adequate to allow for compliance with the requirements of this protocol. 4. patient or his/her legal guardian must sign an informed consent form prior to study participation. 5. patient must be able and willing to comply with all protocol requirements. exclusion criteria: 1. patients who are mentally disabled or are otherwise unable to provide fully informed consent. 2. pregnant or breast-feeding females. 3. patients with evidence of an infection in the targeted zones. 4. patients with known sensitivity to any of the drug components. 5. patients treated by systemic anti psoriatic medications within one month prior to the initial treatment with the as101, or topical anti psoriatic preparations within two weeks prior to the initial treatment with the as101. 6. patient with psoriatic arthritis. 7. patients taking immunosuppressive drugs. 8. immunocompromised patients

Keywords: as101 psoriasis
hnc: human neural circuits electrophysiology during cognition

Conditions: Psychiatric Disorder

Summary: the purpose of this study is to understand how ketamine brings about dissociative symptoms.

the goal of this proposed research is to record the effects of ketamine on brain activity to understand the changes that occur during antidepressant therapy and the side effect of dissociation. this research is designed to probe altered cognitive states associated with dissociation, depression, and other neuropsychiatric conditions.

Eligibility criteria:
inclusion criteria: * patient in clinical neuro inpatient units at stanford medical center * age \>18 years old * female participants are expected to use an effective method of birth control throughout the study which includes: hormonal methods (birth control pills, patches, injections, vaginal ring or implants), barrier methods (condom or diaphragm) used with spermicide, intrauterine device (iud), or abstinence (no sex) exclusion criteria: * lifetime psychotic disorder * pregnant or nursing females * prior adverse ketamine response * use of ketamine in past 7 days
safety and efficacy study of pegylated interferon lambda with and without daclatasvir, compared to pegylated interferon alfa, plus ribavirin in subjects with hepatitis c genotype 2 and 3

Conditions: Hepatitis C Virus (HCV)

Summary: the purpose of this study is to determine if 24 weeks of treatment with pegylated interferon lambda plus ribavirin and 12 weeks of treatment with pegylated interferon lambda plus ribavirin and daclatasvir will be safe and effective for treatment of hepatitis c compared to 24 weeks of treatment with pegylated interferon alfa-2a plus ribavirin


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * chronic hepatitis c, genotype 2 or 3 * naïve to prior anti-hcv therapy exclusion criteria: * infected with hcv other than genotype 2 or 3 * positive hepatitis b surface antigen (hbsag), or human immunodeficiency virus-1 (hiv-1)/hiv-2 antibody at screening * evidence of liver disease other than hcv * active substance abuse * evidence of decompensated cirrhosis
documented candida or aspergillus infections in pediatric patients (0991-043)

Conditions: Aspergillosis; Candidiasis

Summary: this study is an open label, noncomparative study using an investigational agent for the treatment of documented candida or aspergillus infections in pediatric patients (ages 3 months-17 years).


Eligibility criteria:
* children, 3 months through 17 years of age, * with esophageal candidiasis or * invasive candidiasis or * children requiring salvage treatment of invasive aspergillosis.
bioequivalence study of losartan potassium and hydrochlorothiazide (100 mg / 25 mg tablet) [test formulation, torrent pharmaceuticals ltd., india] versus hyzaar® (100 mg / 25 mg tablet) [reference formulation, merck & co., inc., usa] in healthy human volunteers under fed conditions

Conditions: Healthy

Summary: objective: to compare the single dose bioavailability of torrent's losartan potassium and hydrochlorothiazide tablets 1 × 100/25mg and hyzaar® tablets 1 × 100/25mg of merck \& co., inc. study design: randomized, two-way crossover, single-dose, open-label in 70 healthy human adult subjects


Eligibility criteria:
inclusion criteria: * the volunteers were excluded from the study based on the following criteria: * sex: male. * age: 18 - 45 years. . * volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. * healthy and willing to participate in the study. * volunteer willing to adhere to the protocol requirements and to provide written informed consent. * non-smokers or smoker who smokes less than 10 cigarettes per day exclusion criteria: * the volunteers were excluded from the study based on the following criteria: * clinically relevant abnormalities in the results of the laboratory screening evaluation. * clinically significant abnormal ecg or chest x-ray. * systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. * pulse rate less than 50/minute or more than 100/minute. * oral temperature less than 95°p or more than 98.6°p. * respiratory rate less than 12/minute or more than 20/minute * history of allergy to the test drug or any drug chemically similar to the drug under investigation. * history of alcohol or drug abuse * positive breath alcohol test * recent history of kidney or liver dysfunction. * history of consumption of prescribed medication since last 14 days or otc medication since last 07 days before beginning of the study. * volunteers suffering from any chronic illness such as arthritis, asthma etc. * history of heart failure. * hiv, hcv, hbsag positive volunteers. * opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, cocaine positive volunteers based on urine test. * volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. * administration of any study drug in the period 0 to 3 months before entry to the study. * history of significant blood loss due to any reason, including blood donation in the past 3 months. * history of pre-existing bleeding disorder. * existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. * inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
the effectiveness of local dry cold, hot and vibration applications in peripheral intravenous catheterization

Conditions: Pain Management; Emergency Unit; Diarrhea; Nausea; Vomiting

Summary: aim: the aim of the present study was to examine the effect on venous dilation, procedure duration and pain severity of local hot, cold and vibration applications performed on the intervention area before peripheral intravenous catheterization in adults. methods: the study included 120 adults who were randomly selected between march and august 2023. one application group (n=30) received local hot application, one group (n=30) received local cold application, and one (n=30) received local vibration using the buzzy® device. the applications, to the site of the peripheral intravenous catheterization, lasted one minute. the control group (n=30) the received standard peripheral intravenous catheterization application. the groups' venous dilation was assessed on the vein assessment scale and the level of pain felt during catheterization was assessed using a visual analog scale.


Eligibility criteria:
inclusion criteria: * being in accordance with time and place * being aged between 18 and 65 years * being able to evaluate the visual analog scale correctly * participating voluntarily in the research. exclusion criteria: * not participating voluntarily in the research * not fitting the inclusion criteria of the research * having a vision or hearing problem * having a mastectomy * having any illness which could affect pain perception, such as sensory-motor disorder, diabetes, peripheral vascular diseases or peripheral neuropathy * having an allergy to heat and cold application * having phlebitis, scar tissue, dermatitis, an incision or findings of infection at the place where the intervention was to be performed * having taken an analgesic (within the previous six hours) or an anesthetic agent before the peripheral intravenous catheterization procedure

Keywords: hot application cold application peripheral intravenous catheterization venous dilation pain vibration
comparison of curosurf and infasurf in the treatment of preterm infants with respiratory distress syndrome

Conditions: Respiratory Distress Syndrome

Summary: premature infants frequently have trouble breathing after birth. if the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the infant through a tube inserted into the windpipe. this study will compare the safety of two of the commonly used surfactants, poractant and calfactant,in the united states. poractant has added chemicals called phospholipids which are known to cause inflammation and irritation in the body of premature infants. the investigators will compare this to another similar surfactant that does not contain these chemicals by looking at samples from the windpipe, while the tube is in place, and from blood tests in the first few days of life. the investigators are hoping to learn whether calfactant is a safer therapeutic agent to treat respiratory distress syndrome in preterm infants compared to poractant.

30 infants were randomized to receive either poractant or calfactant for respiratory distress syndrome. tracheal aspirates were obtained to look for increase in macrophage and blood samples were drawn to look for markers of inflammation.

Eligibility criteria:
inclusion criteria: * enrolled prior to delivery with signed informed consent and hipaa by parents * gestational age of less than 35 weeks * no maternal chorioamnionitis of other maternal or fetal infection * respiratory distress syndrome (rds) determined by the attending neonatologist that needs to be treated with exogenous surfactant and mechanical ventilation exclusion criteria: * major birth defect, malformation syndrome * chromosomal or inherited metabolic disorder * proven presence of an immunodeficiency * antenatal exposure of illicit substance (e.g., methamphetamines, cocaine, etc., but not marijuana) * birth asphyxia (cord ph \<7.0, apgar score of 3 or less at 10 minutes of age) * hiv or other congenital viral, bacterial or fungal infection * lack of parental consent of refusal of attending neonatologist to allow participation * discretion of the investigator * the legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support

Keywords: surfactant respiratory distress syndrome inflammation c-reactive protein lipid peroxidation
effects of weight on inflammation and colon cancer risk

Conditions: Colorectal Cancer

Summary: an observational study designed to compare colonic cytokine concentrations in lean versus obese individuals

an observational study was performed on 43 individuals undergoing routine screening colonoscopy, some of whom were lean and some who were obese. they had weight, height, and waist-hip ratio measured at the time of colonoscopy and had additional colonic biopsies to measure colonic cytokines.

Eligibility criteria:
inclusion criteria: 1. caucasian 2. undergoing clinically-indicated screening colonoscopy 3. bmi\< or = 25, or 30+ exclusion criteria: 1. past history of cancer (except non-melanoma skin cancer) 2. a polyposis syndrome 3. any current or chronic inflammatory disease or infection 4. incapable of providing valid informed consent

Keywords: obesity inflammation cancer risk
intersphincteric approach to perianal fistula with high risk for postoperative fecal incontinence

Conditions: High Transsphincteric Perianal Fistula

Summary: .rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,it is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .

lay open is the classic surgical management for peri anal fistula,however division of significant portion of anal sphincter may be divided with postoperative fecal incontinence,many surgical techniques have been described for sphincter preservation ,but unfortunately associated high recurrence rate.rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,it is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .the operation is done in tow stages ,the first is to mobilize the transsphincteric part into the inter sphincteric plane thus converting it to intersphincteric fistula which is then laid open , with division of internal sphincter with preserving external sphincter.

Eligibility criteria:
inclusion criteria: * high arching transsphincteric fistula * transsphincteric fistula with high internal opening * transsphincteric fistula with short anal canal. * horseshoe perianal fistula fulfilling above criteria. exclusion criteria: * transsphincteric fistula. * low perianal fistula.
a prospective trial for the effectiveness of the use of spinal cord stimulation (scs) in failed knee surgery

Conditions: Chronic Pain

Summary: a study for patients who have chronic postoperative pain who had knee replacement surgery. if qualified, a 14 day trial and an implantation of spinal cord stimulator for control of pain will be administered. this study will evaluate effectiveness of pain control. subjects will be followed for one year post implantation.

male and female over the age of 18 who have had a total knee replacement at least nine months ago. continue with unilateral knee pain equal to or greater than 4 on a 1 to 10 scale. subjects will receive a trial placement of spinal cord stimulator for 5 to 10 days. if trial is successful subjects will proceed to permanent placement of stimulator for the treatment of the knee pain. subjects will then be followed post implant to assess the effectiveness of the stimulator for the pain.

Eligibility criteria:
inclusion criteria: * over 18 years old * total knee replacement at least nine months prior to enrollment * unilateral knee pain at least 4 or more on a 1-10 visual analog scale * failed other conservative treatments - exclusion criteria: * life expectancy of at least 6 months * significant disease including complex regional pain syndrome,ipsilateral radiculopathy * presence of pacemaker/vns or other spinal cord stimulator * previous lumbar surgery * active infection * unable to hold anticoagulants

Keywords: chronic pain from failed knee surgery